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New heart preservation method could expand donor pool for transplants

NCT ID NCT05881278

Disease control Sponsor: XVIVO Perfusion Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study looks at a new way to keep donor hearts healthy during transport for transplantation. It involves 141 adults with heart failure who are on the transplant list. The goal is to see if this method is safe and effective for using hearts from extended criteria donors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 141 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Recipient Inclusion Criteria: 1. Age ≥18 years. 2. Signed informed consent form (ICF). 3. Listed for heart transplantation Recipient Exclusion Criteria: 1. Previous solid organ or bone marrow transplantation. 2. Requires a multi-organ transplant. 3. Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted). 4. Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump. 5. History of complex congenital heart disease ie: single ventricle physiology (Per Investigators discretion). 6. Subject on renal replacement therapy/dialysis. 7. Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent). 8. Sensitized subject is undergoing desensitization treatment. Donor Inclusion Criteria: 1. Estimated Cross Clamp Time ≥ 4 hours, OR 2. Estimated Cross Clamp Time ≥ 2 hours, AND Any ONE or more of the following: * Age ≥ 50 years * LVEF 40-50% at time of provisional acceptance * Down-time ≥ 20 mins * Hypertrophy/Septal thickness \>12- ≤16mm * Angiographic luminal irregularities with no significant CAD, OR 3. Donation after Circulatory Death (DCD) donors. Donor Exclusion Criteria: 1. Unstable hemodynamics requiring high-dose inotropic support. 2. Significantly abnormal coronary angiogram defined as CAD \> 50% stenosis of one or more vessels. 3. Moderate to severe cardiac valve pathology. 4. Investigator's clinical decision to exclude from trial. 5. Previous Sternotomy.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure Transplant, failure, heart

Contacts and locations

Locations

  • Cedars-Sinai

    Los Angeles, California, 90048, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center/New York Presbyterian Hospital

    New York, New York, 10032, United States

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Johns Hopkins Medicine

    Baltimore, Maryland, 21287, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Stanford Medicine

    Palo Alto, California, 94304, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of California San Diego

    La Jolla, California, 92037, United States

  • University of Maryland Medical Center/University of Maryland, Baltimore

    Baltimore, Maryland, 21201, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

  • Washington University - Barnes Jewish Hospital

    St Louis, Missouri, 63110, United States

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